LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study (LUX-Dx PERFORM)

Boston Scientific

Status: Completed

Conditions: Syncope; Atrial Fibrillation; Cryptogenic Stroke

Study type: Observational

Funder types: Industry

Identifiers

NCT04732728

92557593

Details and patient eligibility

About

The LUX-Dx PERFORM Study had two primary objects which were (1) to characterize, in a general patient population, the utilization of the remote programming feature of the Boston Scientific (BSC) Insertable Cardiac Monitor (ICM) device and (2) to collect data to characterize the performance of arrhythmia detection algorithms. Data was also collected to characterize the ICM system related safety events.

Enrollment: 727 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient is indicated to be implanted with the LUX-Dx ICM for one of the following reasons (grouped in three "Reason for Monitoring" subgroups): 1) Cryptogenic stroke, 2) Syncope, 3) AF management, Post-AF ablation, or Suspected AF
• Patient is willing to enroll and be monitored in LATITUDE Clarity.
• Patient is willing and able to be followed remotely via the ICM patient mobile app.
• Patient is willing and capable of providing informed consent (which is not to include the use of a legally authorized representative (LAR) for documentation of informed consent) and agrees to participate in all protocol required activities.
• Patient is age 18 years or above, or of legal age to give informed consent specific to state and national law.

The following inclusion criterion is applicable for patients participating in the Holter study:

• Patient can tolerate the adhesive used in the Holter monitoring for an extended period of time.

Exclusion criteria

• Patient is indicated for implantation of, or is currently implanted with an active implantable cardiac device (e.g., LVAD, ICD, CRT D, PPM*).
• Patient cannot tolerate a subcutaneous, chronically-inserted device due to medical condition.
• Patient has a documented life expectancy of less than 12 months (per investigator's discretion).
• Patient is known to be pregnant at the time of study enrollment (method of assessment upon investigator's discretion).
• Patient is currently enrolled in another clinical study including observational studies/registries, unless prior written approval from BSC is obtained. Mandatory governmental registries are accepted for co-enrollment without approval by BSC.

The following exclusion criteria are applicable for patients participating in the Holter study:

• Patient has known allergies to the adhesive materials or hydrogel used in the extended Holter monitoring.
• Patient has broken, damaged, or irritated skin over the chest area where the extended Holter monitor will be attached.

Trial design

727 participants in 1 patient group

LUX-Dx PERFORM Study Enrollment

Description:

The first 227 subjects enrolled in the study belong to the "Safety Cohort". The number of subjects is required to fulfill the sample size requirement of the primary safety endpoint. The "Safety Cohort" subjects are not required to participate in the Holter study. Once the "Safety Cohort" enrollment is completed, all subsequent subjects are required to participate in the Holter study. All subjects who participate in the Holter study belong to the "Holter Cohort".